A Parasiticide for the Treatment and
Control of Internal and External Parasites of Cattle and Swine

IVOMEC (ivermectin) is an injectable
parasiticide for cattle and swine. One low-volume dose effectively treats and
controls the following internal and external parasites that may impair the
health of cattle and swine: gastrointestinal roundworms (including inhibited Ostertagia
ostertagi in cattle), lungworms,
grubs, sucking lice, and mange mites of cattle; and gastrointestinal roundworms,
lungworms, lice, and mange mites of swine. Discovered and developed by
scientists from Merck Research Laboratories, ivermectin is a novel chemical
entity. Its convenience, broad-spectrum efficacy, and safety margin make IVOMEC
Injection a unique product for parasite control of cattle and swine.

PRODUCT DESCRIPTION

Ivermectin is derived from the avermectins, a family of potent, broad-spectrum
antiparasitic agents isolated from fermentation of Streptomyces
avermitilis.

IVOMEC Injection is a clear, ready-to-use, sterile solution containing 1%
ivermectin, 40% glycerol formal, and propylene glycol, q.s. ad 100%. IVOMEC
Injection is formulated to deliver the recommended dose level of 200 mcg
ivermectin/kilogram of body weight in cattle when given subcutaneously at the
rate of 1 mL/110 lb (50 kg). In Swine, IVOMEC Injection is formulated to deliver
the recommended dose level of 300 mcg ivermectin/kilogram body weight when given
subcutaneously in the neck at the rate of 1 mL per 75 lb (33 kg).

MODE OF ACTION

Ivermectin is a member of the macrocyclic lactone class of endectocides which
have a unique mode of action. Compounds of the class bind selectively and with
high affinity to glutamate-gated chloride ion channels which occur in
invertebrate nerve and muscle cells. This leads to an increase in the
permeability of the cell membrane to chloride ions with hyperpolarization of the
nerve or muscle cell, resulting in paralysis and death of the parasite.
Compounds of this class may also interact with other ligand-gated chloride
channels, such as those gated by the neurotransmitter gamma-aminobutyric acid
(GABA).

The margin of safety for compounds of this class is attributable to the fact
that mammals do not have glutamate-gated chloride channels, the macrocyclic
lactones have a low affinity for other mammalian ligand-gated chloride channels
and they do not readily cross the blood-brain barrier.

INDICATIONS

Cattle: IVOMEC
Injection is indicated for the effective treatment and control of the following
harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice,
and mange mites in cattle:

Gastrointestinal
Roundworms (adults and
fourth-stage larvae):

Ostertagia ostertagi (including
inhibited O.
ostertagi)

O. lyrata

Haemonchus placei

Trichostrongylus axei

T. colubriformis

Cooperia oncophora

C. punctata

C. pectinata

Oesophagostomum radiatum

Bunostomum phlebotomum

Nematodirus helvetianus (adults
only)

N. spathiger (adults only)

Lungworms (adults
and fourth-stage larvae):

Dictyocaulus viviparus

Cattle Grubs (parasitic
stages):

Hypoderma bovis

H. lineatum

Sucking Lice:

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

Mites (scabies):

Psoroptes ovis (syn. P.
communis var. bovis)

Sarcoptes scabiei var. bovis

Persistent Activity

IVOMEC Injection has been proved to effectively control infections and to
protect cattle from reinfection with Dictyocaulus
viviparus andOesophagostomum
radiatum for 28 days after
treatment; Ostertagia
ostertagi,Trichostrongylus
axei and Cooperia
punctata for 21 days after
treatment;Haemonchus
placei and Cooperia
oncophora for 14 days after
treatment.

Swine: IVOMEC
Injection is indicated for the effective treatment and control of the following
harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites
in swine:

Sows must be treated at least seven days before farrowing to prevent infection
in piglets.

Lungworms:

Metastrongylus spp. (adults)

Lice:

Haematopinus suis

Mange Mites:

Sarcoptes scabiei var. suis

Ivermectin Use (Off-Label) in Dogs and Cats:

Ivermectin injection is given as a liquid orally to dogs
as heartworm preventative. This is a common practice with breeders, animal
shelters and humane societies. Proper dosing and a heartworm test is essential.
Avoid giving to Collies. Shetland Sheepdogs and their crosses as these breeds
are sensitive to ivermectin. Consult with your veterinarian for dosing
instructions.

Ivermectin injection is also given orally, by injection and
topically in the ear for control and treatment of mites - ear mites and skin
mites (mange). Consult with your veterinarian for dosing instructions.

DOSAGE

Cattle: IVOMEC Injection should
be given only by subcutaneous injection under the loose skin in front of or
behind the shoulder at the recommended dose level of 200 mcg of ivermectin per
kilogram of body weight. Each mL of IVOMEC contains 10 mg of ivermectin,
sufficient to treat 110 lb (50 kg) of body weight (maximum 10 mL per injection
site).

Body Weight (lb)

Dose Volume (mL)

220

2

330

3

440

4

550

5

660

6

770

7

880

8

990

9

1100

10

Swine: IVOMEC Injection should be
given only by subcutaneous injection in the neck of swine at the recommended
dose level of 300 mcg of ivermectin per kilogram (2.2 lb) of body weight. Each
mL of IVOMEC contains 10 mg of ivermectin, sufficient to treat 75 lb of body
weight.

Body Weight (lb)

Dose Volume (mL)

Growing Pigs

19

1/4

38

1/2

75

1

150

2

Breeding Animals

(Sows, Gilts, and Boars)

225

3

300

4

375

5

450

6

ADMINISTRATION

Cattle:IVOMEC
Injection is to be given subcutaneously only, to reduce risk of potentially
fatal clostridial infection of the injection site.Animals should be
appropriately restrained to achieve the proper route of administration. Use of a
16-gauge 1/2” to 3/4” needle is suggested. Inject under the loose skin in front
of or behind the shoulder (see illustration).

When using the 200, 500 or 1000 mL pack size, use only automatic syringe
equipment.

Use sterile equipment and sanitize the injection site by applying a suitable
disinfectant. Clean, properly disinfected needles should be used to reduce
the potential for injection site infections.

No special handling or protective clothing is necessary.

Swine: IVOMEC® (ivermectin)
Injection is to be given subcutaneously in the neck. Animals should be
appropriately restrained to achieve the proper route of administration. Use
of a 16- or 18-gauge needle is suggested for sows and boars, while an 18- or
20-gauge needle may be appropriate for young animals. Inject under the skin,
immediately behind the ear (see illustration).

When using the 200 mL, 500 mL or 1000 mL pack size, use only automatic
syringe equipment. As with any injection, sterile equipment should be used.
The injection site should be cleaned and disinfected with alcohol before
injection. The rubber stopper should also be disinfected with alcohol to
prevent contamination of the contents. Mild and transient pain reactions may
be seen in some swine following subcutaneous administration.

Recommended Treatment Program

Swine: At the time of
initiating any parasite control program, it is important to treat all
breeding animals in the herd. After the initial treatment, use IVOMEC
Injection regularly as follows:

Boars: Frequency
and need for treatments are dependent upon exposure. Treat at least two
times a year.

FEEDER PIGS

(Weaners/Growers/Finishers)

All weaner/feeder pigs should be treated before placement in clean quarters.

Pigs exposed to contaminated soil or pasture may need retreatment if
reinfection occurs.

NOTE:

(1) IVOMEC Injection has a persistent drug level sufficient to control mite
infestations throughout the egg to adult life cycle. However, since the
ivermectin effect is not immediate, care must be taken to prevent
reinfestation from exposure to untreated animals or contaminated facilities.
Generally, pigs should not be moved to clean quarters or exposed to
uninfested pigs for approximately one week after treatment. Sows should be
treated at least one week before farrowing to minimize transfer of mites to
newborn baby pigs.

(2) Louse eggs are unaffected by IVOMEC Injection and may require up to
three weeks to hatch. Louse infestations developing from hatching eggs may
require retreatment.

(3) Consult a veterinarian for aid in the diagnosis and control of internal
and external parasites of swine.

Special Minor Use

Reindeer: For the treatment
and control of warbles (Oedemagena
tarandi) in reindeer, inject
200 micrograms ivermectin per kilogram of body weight, subcutaneously.
Follow use directions for cattle as described under ADMINISTRATION.

American Bison: For the
treatment and control of grubs (Hypoderma
bovis) in American bison,
inject 200 micrograms ivermectin per kilogram of body weight,
subcutaneously. Follow use directions for cattle as described under ADMINISTRATION.

WARNING

NOT FOR USE IN HUMANS.

Keep this and all drugs out of
the reach of children.

PRECAUTIONS

Transitory discomfort has been observed in some cattle following
subcutaneous administration. A low incidence of soft tissue swelling at the
injection site has been observed. These reactions have disappeared without
treatment. For cattle, divide doses greater than 10 mL between two injection
sites to reduce occasional discomfort or site reaction. Use sterile
equipment and sanitize the injection site by applying a suitable
disinfectant. Clean, properly disinfected needles should be used to reduce
the potential for injection site infections.

Observe cattle for injection site reactions. Reactions may be due to
clostridial infection and should be aggressively treated with appropriate
antibiotics. If injection site infections are suspected, consult your
veterinarian.

This product is not for intravenous or intramuscular use.

Protect product from light.

IVOMEC Injection for Cattle and Swine has been developed specifically for
use in cattle, swine, reindeer, and American bison only.
This product should not be used in other animal species as severe adverse
reactions, including fatalities in dogs, may result.

Restricted Drug (California) - use only as directed.

When to Treat Cattle with Grubs

IVOMEC effectively controls all stages of cattle grubs. However, proper
timing of treatment is important. For most effective results, cattle should
be treated as soon as possible after the end of the heel fly (warble fly)
season. Destruction of Hypoderma larvae
(cattle grubs) at the period when these grubs are in vital areas may cause
undesirable host-parasite reactions including the possibility of fatalities.
Killing Hypoderma
lineatum when it is in the
tissue surrounding the esophagus (gullet) may cause salivation and bloat;
killing H.
bovis when it is in the
vertebral canal may cause staggering or paralysis. These reactions are not
specific to treatment with IVOMEC, but can occur with any successful
treatment of grubs. Cattle should be treated either before or after these
stages of grub development. Consult your veterinarian concerning the proper
time for treatment. Cattle treated with IVOMEC after the end of the heel fly
season may be retreated with IVOMEC during the winter for internal
parasites, mange mites, or sucking lice without danger of grub-related
reactions. A planned parasite control program is recommended.

Environmental Safety

Studies indicate that when ivermectin comes in contact with soil, it readily
and tightly binds to the soil and becomes inactive over time. Free
ivermectin may adversely affect fish and certain aquatic organisms. Do not
permit water runoff from feed lots to enter lakes, streams or ponds. Do not
contaminate water by direct application or by improper disposal of drug
containers. Dispose of containers in an approved landfill or by
incineration.

As with other avermectins, ivermectin is excreted in the dung of treated
animals and can inhibit the reproduction and growth of pest and beneficial
insects that use dung as a source of food and for reproduction. The
magnitude and duration of such effects are species and life-cycle specific.
When used according to label directions, the product is not expected to have
an adverse impact on populations of dung-dependent insects.